Use of Neuromuscular Electrostimulation (NMES) for Treatment or Prevention of ICU-Associated Weakness

NCT00709124 | Completed Results

• 1 other identifier: NA_00017423
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate whether neuromuscular electrostimulation (NMES) will decrease ICU-associated weakness. The investigators believe that 60 minutes of daily NMES will improve strength and function in those who have had extended ICU stays, as well as decrease critical illness myopathy as an etiology of weakness in the critically ill.

Conditions

Intensive Care Unit; Muscle Weakness

Keywords

Respiration, Artificial; Critical Illness; Intensive Care Units; Electric Stimulation Therapy; Muscle Weakness; Paresis; Mechanically; Ventilated; Patients; Admitted; Medical

Outcome Measures

Primary Outcomes (1)

• Lower Extremity Strength, at Hospital Discharge, of 3 Bilateral Muscle Groups (Pretibial, Triceps Surae, and Quadriceps) Measured Via MMT Using a Composite Medical Research Council (MRC) Score

  Range 0 to 30 with higher score better. The composite score is a simple sum of the individual scores from the 3 bilateral muscle groups

  At hospital discharge

Secondary Outcomes (14)

• Individual Muscle Strength Using Handheld Dynamometry: Tibialis Anterior, Gastrocnemius, and Quadriceps Muscle Strength

  ICU and hospital discharge

• Overall Body Strength

  ICU and hospital discharge

• Hand Grip Strength

  ICU and hospital discharge

• Respiratory Muscle Strength

  ICU and hospital discharge

• Functional Status Measured Using Functional Status Score for the Intensive Care Unit

  ICU and hospital discharge

Study Arms (2)

NMES

EXPERIMENTAL

60 minute daily NMES sessions every day for the duration of subject's ICU stay.

Device: Neuromuscular Electrostimulation (NMES) CareStim Muscle Stimulation Device (Care Rehab; McLean, VA)

Sham

SHAM COMPARATOR

60 minute sham sessions every day for the duration of subjects ICU stay. No voltage will be applied to those receiving sham sessions.

Device: Sham

Interventions

Neuromuscular Electrostimulation (NMES) CareStim Muscle Stimulation Device (Care Rehab; McLean, VA) DEVICE

60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay.

Also known as: CareStim Muscle Stimulation Device (Care Rehab; McLean, VA)

NMES

Sham DEVICE

60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay. Sham groups will NOT have voltage applied.

Also known as: CareStim Muscle Stimulation Device (Care Rehab; McLean, VA)

Sham

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• day of mechanical ventilation with an expectation of requiring ≥2 additional days of ICU stay in a Johns Hopkins Intensive Care Unit (ICU)

You may not qualify if:

• Unable to understand or speak English due to language barrier or cognitive impairment prior to admission
• Unable to independently transfer from bed to chair at baseline prior to hospital admission
• Known primary systemic neuromuscular disease (e.g. Guillian-Barre) at ICU admission
• Known intracranial process that is associated with localizing weakness (e.g. cerebral vascular accident) at ICU admission
• Transferred from another ICU outside of the Johns Hopkins system after \>4 consecutive days of mechanical ventilation
• Moribund (i.e. \>90% probability of patient mortality in the next 96 hours)
• Anticipated transfer to another ICU for care (e.g. awaiting organ transplantation and transfer to surgical ICU)
• Any pacemaker (e.g., cardiac, diaphragm) or implanted cardiac defibrillator
• Pregnancy
• Body mass index ≥35 kg/m2
• Any limitation in life support other than a sole no-CPR order
• Known or suspected malignancy in the legs
• Unable to treat or evaluate both lower extremities (e.g., bilateral amputation, bilateral skin lesions)
• ICU length of stay \>7 days prior to enrollment

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Related Publications (3)

• Kho ME, Truong AD, Zanni JM, Ciesla ND, Brower RG, Palmer JB, Needham DM. Neuromuscular electrical stimulation in mechanically ventilated patients: a randomized, sham-controlled pilot trial with blinded outcome assessment. J Crit Care. 2015 Feb;30(1):32-9. doi: 10.1016/j.jcrc.2014.09.014. Epub 2014 Sep 22.

  PMID: 25307979 DERIVED

• Kho ME, Truong AD, Brower RG, Palmer JB, Fan E, Zanni JM, Ciesla ND, Feldman DR, Korupolu R, Needham DM. Neuromuscular electrical stimulation for intensive care unit-acquired weakness: protocol and methodological implications for a randomized, sham-controlled, phase II trial. Phys Ther. 2012 Dec;92(12):1564-79. doi: 10.2522/ptj.20110437. Epub 2012 Mar 15.

  PMID: 22421734 DERIVED

• Needham DM, Truong AD, Fan E. Technology to enhance physical rehabilitation of critically ill patients. Crit Care Med. 2009 Oct;37(10 Suppl):S436-41. doi: 10.1097/CCM.0b013e3181b6fa29.

  PMID: 20046132 DERIVED

MeSH Terms

Conditions

Muscle Weakness; Respiratory Aspiration; Critical Illness; Paresis

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Disease Attributes

Results Point of Contact

• Title: Dr Dale Needham
• Organization: Johns Hopkins University School of Medicine

dale.needham@jhmi.edu

(410) 955-3467

Study Officials

• Dale Needham, MD, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2008
• First Posted: July 3, 2008
• Study Start: June 1, 2008
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: January 23, 2018
• Results First Posted: April 16, 2015

Record last verified: 2018-01

Locations

US (1)